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Quality Assurance Manager

Julphar Pharmaceutical PLC

Addis Ababa

8 years - 10 years

1 Position

2023-05-16

to

2023-05-23

Required Skills
Required skills have not yet been specified for this position this job
Fields of study

Pharmacy

Full Time

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Job Description

Julphar Pharmaceuticals PLC is a joint venture between Gulf Pharmaceuticals Industries (Julphar) U.A.E and MEDTECH Ethiopia, which is involved in the manufacturing of LIFE SAVING Drugs for the local Ethiopian market use as well as for export. Julphar is looking for new candidates with big ambitions, potentials and commitment to improve the quality of life for our end customers.

Job Summary/Main Purpose

Quality Assurance Manager is responsible for the guidance, control, and follow-up of various QA Operations: Documentation, Internal and external Auditing, Product Quality Review, Validation/ Qualification of process/ Equipment/ Method, and Training activities within the organization.

Main Responsibilities:

Under the guidance of Plant Manager, the QA Manager carries out the following duties:

  • Assures total management, supervision, and control of quality Assurance work and personnel.

  • Establishment, implementation, and maintenance of the Quality policy; to help ensure that Julphar Pharmaceutical PLC. (Ethiopia) products consistently meet pre-determined requirements and specifications.

  • Ensure that Julphar Pharmaceuticals PLC. (Ethiopia) complies with current local and international cGMP standards.

  • Preparation and review of Site Master File, Quality Manual, Validation Master File, and other Quality system documents (as required).

  • Ensure that the appropriate Qualification/validations/ re-qualification/ re-validation of manufacturing equipment, cleaning procedures and utility systems (HVAC System and Purified Water treatment system) are carried out.

  • Supervise, and participate in the preparation of training and training assessment materials based; on cGMP, both local and international regulatory guidelines, and in-house SOPs and conduct training for employees as per their training need identification and as required (following audit, CAPA, change, deviation, and non-compliance reports).

  • Monitor Change Management, Deviations control, OOS/OOT investigations, and CAPA programs and prepare reports.

  • Review specifications, testing procedures, stability protocols, SOP, and other technical documents Changes to ensure compliance with cGMP and other quality policies.

  • Participate in GMP Vendor Qualification program by utilizing a risk based strategy which includes a combination vendor questionnaires and on-site auditing.

  • Responsible for evaluating impending regulations, guidelines and industry standards and their impact on the company and contract operations (if any).

  • Provide expert advice on issues related to quality to colleagues. Build quality systems in support of a GMP manufacturing facility. Interpret and implement regulatory guidance rules.

  • Performs other duties in accordance with the instruction issued by the plant Manager.

Division: Quality Assurance

Reporting to: Plant Manager

Number Required : One 

Job Requirements

Qualifications: 

  • Masters in pharmacy or BA Degree in Pharmacy with 8/10 years of experience of which 4 years proven experience in pharmaceutical sector on supervisory position.

Skills Required:

  • Good interpersonal skill and communication skills

  • Knowledge on the rules and regulations (both local and international) governing the pharmaceutical and the health sector in general.

  • Have good knowledge and understanding about current Good Manufacturing Practice.

  • Basic computer skill (with good command of Microsoft office tools and additional soft wares).

  • Demonstrate high level of personal motivation, initiative, and leadership skill.

  • Ability and willingness to work and participate effectively in a team environment.

How to Apply

Submit your CV and credential in a single Pdf Format via email: julpharethiopia@gmail.com

Fields Of Study

Pharmacy